Day One - EST/EDT (Eastern Daylight, GMT-4)
Day One - EST/EDT (Eastern Daylight, GMT-4)
Though specifically authorized in the federal Food, Drug & Cosmetic Act, some restrictions on compounded drug therapies threaten patient access, and many of the restrictions are not rooted in science. In this session, the Alliance for Pharmacy Compounding’s CEO Scott Brunner, CAE, will brief attendees on the following:
- USP’s restrictions on beyond-use dates and batch sizes for compounded meds
- FDA’s threat to restrict compounded hormone therapy
- As California Goes: Proposed regulations exceed national standards
- The need for 503A compounders to prepare shortage drugs for urgent use
- Proscriptions on Peptides and the reclassification of DTE
- Proposed legislation to eliminate the MOU and implement 503A adverse event reporting
- Scott Brunner, CAE - Chief Executive Officer, Alliance for Pharmacy Compounding (A4PC)
- Nuances in chapter changes and the “why” behind the revisions
- What effects will the new revisions have on 503A and 503B pharmacies?
- Designated Person responsibilities
- New implications for old compounds
- Melissa Stefko - Senior Director of Quality, The Flexpro Group
- Matt Martin, PharmD BCSCP - Director of Clinical Services, PCCA
- Facility updates considering revisions – initial costs are heavy
- Impacts for small companies and how to sustain substantial price increases
- Challenges with supply chain
- Jason McGuire - Vice President, Global Quality, Fagron Sterile Services
- A.J Day - Vice President of Clinical Services, Professional Compounding Centers of America
An FDA inspection can be a very stressful experience and can pose significant risk for pharmacies, compounding pharmacies and outsourcing facilities. That’s why it is important to be prepared. This session will cover the nuts and bolts of an FDA inspection of a compounding facility and provide useful tips and tricks on navigating FDA’s visit. The session will also cover what happens after the inspection, including FDA’s process and potential outcomes. Finally, the session will discuss ways to remain proactive as opposed to reactive when it comes to FDA audits and inspections, in order to put your facility in the best position possible for a future FDA inspection.
- Rachael Pontikes - Partner, Reed Smith LLC
- Emily Hussey - Partner, Reed Smith LLP
- How to build facilities – What to consider if starting a facility If you were to start from scratch, what should you consider?
- Process workflows
- Clean rooms – Importance of HVAC systems, airflow, and pressure requirements.
- Sara Cheikelard - Architect, DLR Group
- DJ Acker - Senior Mechanical Engineer, Controlled Environment Consulting
From a raw powder to a final product, testing and quality assurance is continuously addresses the following topics
- Most suitable testing methods
- Process of sterility testing
- environmental monitoring requirements from state boards and FDA
- Allison Gentile, PharmD - Director of Quality, Pine Pharmaceuticals
- Lisa McChesney-Harris, PhD - Founding Member, Prompt Praxis Laboratories, LLC
USP outlines a risk assessment process to consider the true nature of hazardous drugs. This session will start out by discussing USP 800 and then delve into topics such as:
- Determining specific drugs for hazardous drug risk list.
- Selecting different categories for these risks.
- Exploring the possibility of standardized risk across the compounding space
- Katrina K. Harper - Director of Clinical Education, AIS Healthcare
- Jessica Lee, BS, PharmD, BCSCP - Pharmacy Compounding Supervisor, Memorial Cancer Institute
- John Daniel, PharmD, MHA, BCNP - Clinical Pharmacist II, Christus Mother Frances Hospital
Establishing and maintaining the state of control within the sterile compounding area is essential in ensuring patients receive safe medications. Proper facility design, engineering controls, and a robust contamination control strategy can only take you so far. Viable sampling is the only tool we have in determining the microbial state of control in the sterile compounding areas. This requires sterile compounding facilities to have a robust environmental monitoring program with detailed processes on the execution of sampling activities, results evaluation, data trending, targeted improvement metrics, and effective corrective action preventative action plan documentation. To achieve the best quality outcome, the environmental monitoring program must go beyond the minimum standard requirements. This presentation will discuss the changes to USP <797> viable sampling requirements and provide insight into industry-accepted best practices.
- Abby Roth - Owner/Microbiologist, Pure Microbiology
- Differences in working with sterile vs nonsterile drugs
- Process and patient safety
- Jeff Baird - Shareholder, Brown & Fortunato
- Christian Stella, PharmD, ABAAHP, FAAMM - CEO, Precision Compounding Pharmacy
Upcoming changes to USP compendial chapters will shorten the shelf life of many compounded products. However, the updates clarify expectations for validating alternative microbial methods. These methods can significantly shorten the time for product release, allowing you to make the most of the product shelf life and batch size planning. This presentation outlines steps you can take to implement a rapid microbial method in your laboratory.
- Jonathan Kallay - Senior Technology and Market Development Manager, Charles River Laboratories
Revisions to USP general chapter <797> on sterile compounding introduce new compounding categories in lieu of the currently official low, medium, and high-risk categories. These new categories are the basis for establishing BUDs and consider the compounding environment, processing method, starting components, and quality control test results of the finished CSP. This presentation will introduce the new compounding categories and focus on the requirements for achieving Category 3 BUDs including terminal sterilization, stability studies, testing, and the increased frequency of personnel qualification and environmental monitoring.
- Ross Caputo - President & CEO, Eagle Analytical
- What are ideal solutions?
- RABS units vs Isolators
- Cost vs benefit
- What are the short-term and long-term approaches?
- Cleaning and disinfecting asceptic compounding rooms
- David Short - Chief Quality Officer, QuVa Pharma